Briviact 75mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Brivaracetam

Available from:

UCB Pharma Ltd

ATC code:

N03AX23

INN (International Name):

Brivaracetam

Dosage:

75mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5015313013635

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRIVIACT 10 MG FILM-COATED TABLETS
BRIVIACT 25 MG FILM-COATED TABLETS
BRIVIACT 50 MG FILM-COATED TABLETS
BRIVIACT 75 MG FILM-COATED TABLETS
BRIVIACT 100 MG FILM-COATED TABLETS
brivaracetam
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Briviact is and what it is used for
2.
What you need to know before you take Briviact
3.
How to take Briviact
4.
Possible side effects
5.
How to store Briviact
6.
Contents of the pack and other information
1.
WHAT BRIVIACT IS AND WHAT IT IS USED FOR
What Briviact is
Briviact contains the active substance brivaracetam. It belongs to a
group of medicines called
‘anti-epileptics’. These medicines are used to treat epilepsy.
What Briviact is used for
Briviact is used in adults and adolescents from 16 years of age to
treat a type of epilepsy characterized
by the occurrence of partial seizures with or without secondary
generalisation’. Partial seizures are fits
that start by only affecting one side of the brain. These partial
seizures can spread and extend to larger
areas on both sides of the brain – this is called a ‘secondary
generalisation’. You have been given this
medicine to lower the number of fits (seizures) you have. Briviact is
used together with other
medicines for epilepsy.
2.

Summary of Product characteristics

OBJECT 1
BRIVIACT FILM-COATED TABLETS
Summary of Product Characteristics Updated 03-May-2017 | UCB Pharma
Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Briviact 10 mg film-coated tablets
Briviact 25 mg film-coated tablets
Briviact 50 mg film-coated tablets
Briviact 75 mg film-coated tablets
Briviact 100 mg film-coated tablets
2. Qualitative and quantitative composition
Briviact 10 mg film-coated tablets
Each film-coated tablet contains 10 mg brivaracetam.
Briviact 25 mg film-coated tablets
Each film-coated tablet contains 25 mg brivaracetam.
Briviact 50 mg film-coated tablets
Each film-coated tablet contains 50 mg brivaracetam.
Briviact 75 mg film-coated tablets
Each film-coated tablet contains 75 mg brivaracetam.
Briviact 100 mg film-coated tablets
Each film-coated tablet contains 100 mg brivaracetam.
Excipient(s) with known effect:
Briviact 10 mg film-coated tablets
Each 10 mg film-coated tablet contains 88 mg lactose.
Briviact 25 mg film-coated tablets
Each 25 mg film-coated tablet contains 94 mg lactose.
Briviact 50 mg film-coated tablets
Each 50 mg film-coated tablet contains 189 mg lactose.
Briviact 75 mg film-coated tablets
Each 75 mg film-coated tablet contains 283 mg lactose.
Briviact 100 mg film-coated tablets
Each 100 mg film-coated tablet contains 377 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablets)
Briviact 10 mg film-coated tablets
White to off-white, round film-coated tablets of 6.5 mm in diameter
and debossed with 'u10' on one side.
Briviact 25 mg film-coated tablets
Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and
debossed with 'u25' on one side.
Briviact 50 mg film-coated tablets
Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm
and debossed with